By ValSource Consultants Beth Fulton and Angelica Welch

A recent article by ValSource Consultants Beth Fulton and Angelica Welch published in the PDA Journal of Pharmaceutical Science and Technology outlines a risk-based approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins.

By ValSource Director of Learning James Vesper, PhD, MPH and Senior Consultant Amanda McFarland, MSC

A recent article by ValSource Director of Learning Solutions James Vesper and Senior Consultant Amanda McFarland published in Pharmaceutical Technology discusses how using the four-phased “Kirkpatrick Model” method in evaluating a QRM can ensure continual improvement and that regulatory requirements are met.

By Danica Brown and Theo Zacharatos, ValSource Inc.

Check out part 2 of the ICH Q9(R1) article series from ValSource colleagues, Danica Brown and Theo Zacharatos. Get detailed insight on subjectivity and product availability risks.

By Stacey Largent, M. Eng. and Virginia Andreotti-Jones, ValSource Inc.

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

By Tiffany Baker, Danica Brown, and Amanda McFarland; ValSource, Inc.

Dive into common risk management pain points and discover mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). Read our recent publication in Outsourced Pharma by ValSource team members: Tiffany Baker, Danica Brown, and Amanda McFarland.

By Michael J. Sadowski and Stephen E. Langille

Read our recent publication in the PDA – Parenteral Drug Association Journal of Pharmaceutical Science & Technology — “Parametric Release of Moist Heat Sterilized Products: History and Current State,” authored by Mike Sadowski, Lead Scientist, Sterility Assurance at Baxter Healthcare Corporation and Stephen Langille, Senior Microbiology Consultant at ValSource Inc.

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Read our recent publication with Outsourced Pharma — “CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance,” authored by ValSource team members Ryan Murray, Senior Consultant & Amanda Bishop McFarland.

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Over the last several years, various revisions of the EU’s Annex 11 have been released and reviewed by countless numbers of subject matter experts across our industry. The final version is now published, and it is time to take action. Read more from Ryan Murray, M.Sc., and Amanda McFarland, M.Sc.

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. These steps comprise the initial technology assessment, data and compliance risk, cost considerations and an overall instrument evaluation.

By Jim Vesper, Ph D., ValSource Inc.

As someone who has been involved in risk management for a number of years, it has been interesting during COVID-19 to step back and reflect on some of my recent decisions and actions: Do we host a holiday party for 80 people? How about a smaller event for 30 people who all claim to have been fully vaccinated? Do we go to a restaurant that requires proof of vaccination? What about that gathering with some friends we haven’t seen in nearly two years but haven’t been vaccinated?

The responses to these questions – and many others – are based on how much risk we are willing to accept or reject, or more specifically in the vocabulary of risk management, our risk appetite and risk tolerance.

This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions.